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Study to evaluate the efficacy and safety of deucrictibant for the prevention and treatment of angioedema attacks in adults with acquired angioedema

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to evaluate the efficacy and safety of deucrictibant (PHA-022121) in adults with Acquired Angioedema due to C1 Inhibitor Deficiency. This condition is a rare disease that causes episodes of swelling, known as angioedema, which often occur in the face, hands, feet, or digestive tract. The research focuses on two different ways to use the medication: to prevent these swelling attacks from happening and to treat them as they occur.

The study is divided into three different parts. In the first part, participants take an extended-release tablet, which is a type of medication designed to release the drug slowly into the body over time, to see if it can prevent attacks. This part compares the drug to a placebo. The second part looks at using a soft capsule, which is a small, gel-like pill, to provide relief during an active attack. This part also compares the medication to a placebo. In the final part, participants receive the medication during an attack to monitor its safety and how well it is tolerated by the body.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Part 1: prophylaxis phase

    The first stage is a 12-week period focused on prophylaxis, which means taking medication to prevent angioedema (swelling) attacks from occurring.

    During this stage, deucrictibant extended-release (xr) tablets at a dose of 40 mg or a placebo (a pill with no active medicine) will be administered orally.

    This part is double-blind, meaning neither the patient nor the medical staff knows which substance is being taken.

  2. Step 2

    Part 2: on-demand treatment phase

    The second stage evaluates on-demand treatment, which involves taking medication at the time an angioedema attack begins to relieve symptoms.

    The medication used is the deucrictibant soft capsule at a dose of 40 mg or a placebo.

    This stage is also double-blind to ensure the results are objective.

  3. Step 3

    Part 3: open-label extension phase

    The final stage is an open-label extension, where the deucrictibant soft capsule is used for on-demand treatment of angioedema attacks.

    Unlike previous stages, this part is open-label, meaning it is known which medication is being administered.

    The focus of this stage is to monitor the safety and how well the body tolerates the medication.

Who can join the trial?

14 criteria

  • You must provide written informed consent, which means you sign a document agreeing to participate in the study after being fully informed about it.
  • You must be male or female (based on your sex at birth) and at least 18 years old at the time you sign the consent form.
  • You must have a confirmed diagnosis of Acquired Angioedema due to C1 Inhibitor Deficiency (AAE-C1INH), which is a condition involving swelling under the skin or on mucous membranes (the moist linings of the body, such as inside the mouth) that is not itchy and is not accompanied by urticaria (hives).
  • Your C1INH functional level, which measures how well a specific protein in your blood works, must be less than 40% as shown by a laboratory test.
  • You must not have a family history of angioedema (swelling under the skin).
  • You must show specific laboratory results, such as low levels of a protein called C1q or a positive test for anti-C1INH autoantibodies (proteins produced by the immune system that mistakenly attack the body's own C1 inhibitor protein).
  • If you are joining Part 1 of the study, you must have a history of angioedema attacks.
  • If you are joining Part 2 and have never taken deucrictibant, you must have had at least two attacks within the 12 weeks immediately before your first screening visit.
  • For Part 1, if you have an underlying condition like lymphoproliferative disease (a group of disorders where too many white blood cells are produced), immune complex disorders, or monoclonal gammopathy of undetermined significance (a condition where an abnormal protein is found in the blood), you must not have received specific treatments like chemotherapy or immunotherapy in the 6 months before your visit.
  • For Part 1, if you have other diseases such as Systemic Lupus Erythematosus (a disease where the immune system attacks the body's own tissues), your maintenance treatment (the regular medicine used to keep the disease under control) must have been stable for at least 6 months.
  • The study doctor must confirm that you can reliably access and use your current available therapy to manage your attacks.
  • Women who are able to become pregnant must agree to regular pregnancy testing and must use contraception (methods to prevent pregnancy) or avoid sexual intercourse from the start of the study until 30 days after the last dose of the study medicine.
  • Women who are postmenopausal (meaning they have not had a period for at least 12 months for medical reasons) or have had certain surgical procedures to prevent pregnancy do not need to use contraception.
  • You must be able to use an electronic device to record your own health information through an eDiary (an electronic daily diary) and ePRO (electronic Patient-Reported Outcomes, which are reports of symptoms provided directly by the patient).

Who cannot join the trial?

13 criteria

  • You cannot participate if you have any other type of recurrent angioedema (repeated swelling under the skin) besides the specific type required for this study.
  • You are excluded if there is evidence of current alcohol or drug abuse.
  • You cannot join if you have used certain medications or foods within the last 30 days (or a specific timeframe based on how long the substance stays in your body) that affect cytochrome P450 (CYP) 3A4, which is a specific way your body processes and breaks down medicines. This includes medicines like certain antibiotics, heart medications, or grapefruit juice.
  • You are excluded if you have a known hypersensitivity (an allergic reaction) to the study drug or any of its excipients (the inactive ingredients used to make the pill or capsule).
  • You cannot participate if you have used angiotensin-converting enzyme inhibitors (a type of blood pressure medicine) or any estrogen-containing medications (hormone medicines) within a specific timeframe before the study starts.
  • You are excluded if you have taken any other investigational drug (a medicine being tested in a clinical trial) within the last 30 days or within a specific timeframe based on how long that drug stays in your system.
  • You cannot join if you have recently received certain types of prophylactic therapy (preventative treatments to stop swelling attacks), such as long-term prophylaxis (LTP) involving specific proteins, inhibitors, or monoclonal antibodies (specialized medicines made in a lab to target specific parts of the immune system), within the time limits specified in the study rules.
  • Any women who are pregnant, planning to become pregnant, or currently breast-feeding cannot participate.
  • You are excluded if you have abnormal hepatic function (problems with how your liver works), measured by high levels of certain liver enzymes or bilirubin (a yellowish substance produced during the breakdown of red blood cells), or if you have a history of significant liver issues. However, people with Gilbert’s syndrome (a common, harmless liver condition that causes slightly high bilirubin) are allowed to participate.
  • You cannot participate if you have moderate or severe renal impairment (kidney problems), which is measured by your estimated glomerular filtration rate (eGFR), a test that shows how well your kidneys filter waste from your blood.
  • You are excluded if you have any serious cardiovascular disease (heart or blood vessel problems), such as angina (chest pain), myocardial infarction (heart attack), syncope (fainting), stroke, or uncontrolled hypertension (high blood pressure), that could make participation unsafe.
  • You cannot join if you have a history of epilepsy (a disorder causing seizures) or other significant neurological diseases (conditions affecting the brain or nervous system).
  • You are excluded if you have any significant and uncontrolled gastrointestinal dysfunction (problems with the stomach or intestines), such as chronic diarrhea or inflammatory bowel disease, that might change how your body absorbs the study medication.
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Investigated drugs

Deucrictibant is a medication being tested to help prevent swelling attacks and to treat attacks as they happen in adults with a specific type of swelling disorder called acquired angioedema. In this study, it is used in two ways: as a tablet taken regularly to prevent swelling from occurring, and as a capsule taken when a swelling attack begins to help relieve symptoms.

What is already known about the treatment

Deucrictibant - This medication is taken by mouth in the form of either an extended-release tablet for prevention or a soft capsule for treating sudden attacks. Currently being studied in late-stage clinical trials, it is being developed to help manage swelling caused by a rare immune system disorder known as acquired angioedema. It works at a molecular level by blocking specific proteins that trigger the inflammatory process and swelling in the body. This drug belongs to a class of medications designed to regulate the immune response.

Investigated diseases

Acquired angioedema due to C1 inhibitor deficiency - This condition involves sudden swelling in different parts of the body, such as the skin, face, or throat. It occurs when a specific protein in the blood that helps control inflammation is not working correctly. This deficiency can be caused by an underlying issue in the immune system. The swelling often appears as temporary episodes that can vary in intensity. These attacks may happen unpredictably and can affect different areas of the body over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522051-26-00Protocol codePHA022121-C308Estimated enrolment32 patientsSponsorPharvaris Netherlands B.V.

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